SENIOR EXECUTIVE

Role Purpose

Supervisor-MFG-DP(Fill Finish)-Aseptic Manufacturing: Manufacturing Operations oversees daily manufacturing activities and ensures the production processes run smoothly and efficiently during their shift. This role involves managing the production team, coordinating with other departments, and troubleshooting any issues that arise. Emphasis is placed on maintaining adherence to operational procedures, meeting production targets, and ensuring compliance with safety and quality standards. Effective communication and leadership skills are essential for optimizing production performance and achieving operational goals.

Work experience (in months)

96

Job Responsibility and key Decisions

Responsible for all sections of production area and plan and execute production to meet business requirements within timelines.

Always ensure data integrity and compliance to quality and regulatory requirements. Also ensure that entryexit, preparation and autoclave, CIP, SIP, formulation, filtration, vial washing, depyrogenation, filling, sealing, Lyophilizer loadingunloading activities are carried out in compliance with the cGMP requirement and as per respective SOPs. Maintain the change parts, spares which are required for all the equipment of the production areas.

Ensure continuous monitoring of BMS i.e. temperature, differential pressure, relative humidity, PMS and their compliance.

Handling of manpower and allocating defined responsibilities to the team in production areas. Micro planning of shift activities of the day, conveying the workflow to the team and taking follow ups for progress of assigned work.

To ensure discipline in the team and aseptic practices are compliant always.

To coordinate with compliance team and QAQMS for documents i.e. change controls, CAPA, Deviations, QRA, Technical document, Study Protocols and reports.

To coordinate with supporting departments i.e. QA, QC, Engineering Maintenance, for achieving the daytoday production targets and compliance.

To ensure facility is following EHS requirements.

Handling of Internal audits and external audits, and to coordinate for department audits.

Review of BMR and SOP.